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Previous Volume 349:2091-2098 November 27, 2003 Number 22 Next

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ABSTRACT

Background Induction chemotherapy with cisplatin plus fluorouracil followed by radiotherapy is the standard alternative to total laryngectomy for patients with locally advanced laryngeal cancer. The value of adding chemotherapy to radiotherapy and the optimal timing of chemotherapy are unknown.

Methods We randomly assigned patients with locally advanced cancer of the larynx to one of three treatments: induction cisplatin plus fluorouracil followed by radiotherapy, radiotherapy with concurrent administration of cisplatin, or radiotherapy alone. The primary end point was preservation of the larynx.

Results A total of 547 patients were randomly assigned to one of the three study groups. The median follow-up period was 3.8 years. At two years, the proportion of patients who had an intact larynx after radiotherapy with concurrent cisplatin (88 percent) differed significantly from the proportions in the groups given induction chemotherapy followed by radiotherapy (75 percent, P=0.005) or radiotherapy alone (70 percent, P<0.001). The rate of locoregional control was also significantly better with radiotherapy and concurrent cisplatin (78 percent, vs. 61 percent with induction cisplatin plus fluorouracil followed by radiotherapy and 56 percent with radiotherapy alone). Both of the chemotherapy-based regimens suppressed distant metastases and resulted in better disease-free survival than radiotherapy alone. However, overall survival rates were similar in all three groups. The rate of high-grade toxic effects was greater with the chemotherapy-based regimens (81 percent with induction cisplatin plus fluorouracil followed by radiotherapy and 82 percent with radiotherapy with concurrent cisplatin, vs. 61 percent with radiotherapy alone). The mucosal toxicity of concurrent radiotherapy and cisplatin was nearly twice as frequent as the mucosal toxicity of the other two treatments during radiotherapy.

Conclusions In patients with laryngeal cancer, radiotherapy with concurrent administration of cisplatin is superior to induction chemotherapy followed by radiotherapy or radiotherapy alone for laryngeal preservation and locoregional control.

Source Information

From the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (A.A.F., D.-J.L.); the University of Texas M.D. Anderson Cancer Center, Houston (H.G., M.M., R.W., W.M., B.G., C.C.); Radiation Therapy Oncology Group Headquarters, Philadelphia (T.F.P.); the H. Lee Moffitt Cancer Center and Research Institute, University of South Florida, Tampa (A.T.); Fox Chase Cancer Center, Philadelphia (J.A.R.); the Department of Radiation Oncology, University of Alabama, Birmingham (G.P.); the Department of Veterans Affairs New York Harbor Healthcare System, Brooklyn (A.L.); the Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit (J.E.); and the Department of Radiation Oncology, New York University Medical Center, New York (J.C.).

Address reprint requests to Dr. Forastiere at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans St., Suite G90, Baltimore, MD 21231-1000, or at af{at}jhmi.edu.

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